Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that PD-L1 >= 1% status confers therapeutic sensitivity to Nivolumab in patients with Bladder Urothelial Carcinoma.
The Republic of Ireland's Health Service Executive (HSE) has approved nivolumab as a monotherapy treatment option for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) with tumour cell PD-L1 expression >= 1%, who are at high risk of recurrence after undergoing radical resection of MIUC, providing patients are unsuitable for adjuvant treatment with platinum based chemotherapy.
This statement is based on a regulatory approval from the Health Service Executive:
As monotherapy for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) with tumour cell PD-L1 expression >= 1%, who are at high risk of recurrence after undergoing radical resection of MIUC, providing patients are unsuitable for adjuvant treatment with platinum based chemotherapy.